The Food and Drug Administration's panel of independent advisers will on June 4 deliberate whether they should recommend approval for the first MDMA-assisted therapy for post-traumatic stress disorder, Lykos Therapeutics said on Monday.
This would be the first FDA panel of outside experts to review a potential new PTSD treatment in 25 years.
PTSD is a disorder caused by very stressful events and can significantly disrupt patients’ lives.
Decades of studies has shown that psychoactive ingredients, whether derived from cannabis, LSD or magic mushrooms, have long captivated mental health researchers in their quest for treatments.
In support of its application, Lykos Therapeutics, formerly known as Multidisciplinary Association for Psychedelic Studies (MAPS), studied the party drug MDMA, more commonly called ecstacy or molly, in two late-stage studies.
The drug is intended to be used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
No psychedelic-based therapy has been approved yet in the U.S., but MAPS and companies such as Compass Pathways are testing such drugs to find cures for a range of mental health disorders.
